Caretaker Medical
Charlottesville, VA, US
CARETAKER MEDICAL appears in FDA device records in Charlottesville, VA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Caretaker Medical between 2016 and 2025. The busiest year on record is 2016, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251275 | VitalStream ART Connect; VitalStream-Hemo | DXG | Substantially Equivalent | |
| K213699 | CareTaker Monitor App | DXN | Substantially Equivalent | |
| K211588 | Caretaker Platform, VitalStream Platform, CT5 | DXN | Substantially Equivalent | |
| K181196 | Caretaker Remote Display App and Caretaker Software Library | DRG | Substantially Equivalent | |
| K163255 | CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor | DXN | Substantially Equivalent | |
| K151499 | CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013319763 | 3013319763 | CARETAKER MEDICAL | 941 Glenwood Station Ln, Charlottesville, VA 22901 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain